1. Field of the Invention
The present invention relates generally to continuous ambulatory peritoneal dialysis (CAPD) methods and systems and, more particularly, to a user wearable device such as a pouch or bag which provides a sterile environment for connecting a catheter to a fill-drain tube for feeding and draining dialysis fluid.
2. Background Art
Continuous ambulatory peritoneal dialysis (CAPD) is a method for performing dialysis for users with kidney failure. CAPD occurs in the user""s peritoneal cavity using dialysis fluid. CAPD functions the same way kidneys do by constantly cleansing the blood as long as there is dialysis fluid in the peritoneal cavity. The dialysis fluid is left in the peritoneal cavity for several hours to collect waste from the blood. The used dialysis fluid is then drained from the peritoneal cavity into a drain bag. Fresh dialysis fluid from a fill bag is then supplied into the peritoneal cavity for the process to start over.
In order to exchange used and fresh dialysis fluid in the peritoneal cavity, a catheter tube (catheter) is permanently attached to the user. An interior end of the catheter is surgically inserted through the user""s abdomen into the user""s peritoneal cavity. An exterior end of the catheter extends out about four inches from the user""s abdomen. The user connects the exterior end of the catheter to the fill bag via a fill-drain tube for receiving fresh dialysis fluid into the user""s peritoneal cavity. Similarly, the user connects the exterior end of the catheter tube to the drain bag via the fill-drain tube for draining used dialysis fluid from the user""s peritoneal cavity. Once the draining and filling operations are completed, the user disconnects the catheter from the fill-drain tube and seals the catheter.
The user must repeatedly exchange used and fresh dialysis fluid about four times a day for CAPD. Each exchange encompasses connecting the exterior end of the catheter tube to the fill-drain tube. A problem with each exchange is that the user must make the connections such that no germs or bacteria are introduced into the catheter tube. Germs or bacteria introduced into the catheter can enter the peritoneal cavity and cause infection. Repeated infections scar the peritoneal cavity and cause pain to the user.
In order to ensure that no germs or bacteria are introduced into the catheter, the user must perform what is known as the xe2x80x9caseptic techniquexe2x80x9d for making the connection between the catheter and the fill-drain tube. The aseptic connection technique includes making the connection between the catheter and the fill-drain tube in a closed environment such as a room. All doors, windows, and vents in the room must be closed and all fans in the room turned off in order to keep the air movement in the room at a minimum. The room should also be void of family activity and pets and occur in a spare bedroom or the like. In general, the aseptic connection technique requires appropriate environmental conditions which limit the mobility and flexibility of the user and require limitations on space resources.
What is needed is a portable device which effectively consolidates the size of a typical closed environment such as a spare bedroom into a much smaller size. Such a portable device would provide a sterile environment for connecting the catheter to the fill-drain tube for an exchange of used and fresh dialysis fluid even when the user is located in an environment unsuitable for the aseptic connection technique. As a result, a user wearing such a portable device while situated within a hostile environment, such as room where the windows are open or on a boat in a lake, could connect the dialysis tubes in order to perform an exchange in a sterile environment thereby satisfying the aseptic connection technique.
Accordingly, it is an object of the present invention to provide a user wearable portable device such as a pouch or bag which provides a sterile environment for connecting the user""s catheter to a fill-drain tube for performing an exchange of used and fresh dialysis fluid.
It is another object of the present invention to provide a user wearable pouch which provides a sterile environment for connecting the user""s catheter to a fill-drain tube for performing an exchange of used and fresh dialysis fluid.
It is a further object of the present invention to provide a user wearable pouch having openings for inserting the user""s catheter and a fill-drain tube into the interior of the pouch such that the user can connect the catheter to the fill-drain tube within the interior of the pouch for draining and feeding dialysis fluid in a sterile environment.
It is still another object of the present invention to provide a user wearable pouch having covered openings for inserting the user""s catheter and a fill-drain tube into the interior of the pouch and having internally disposed hand covering elements in communication with the exterior of the pouch such that the user can insert his hands into the hand covering elements and connect the catheter to the fill-drain tube within the interior of the pouch for performing an exchange of used and fresh dialysis fluid in a sterile environment.
It is still a further object of the present invention to provide a user wearable pouch having covered openings for inserting a user""s catheter and a fill-drain tube into respective sleeves extending into the interior of the pouch such that the user can expose the catheter and the fill-drain tube from the respective sleeves within the interior of the pouch and connect the catheter to the fill-drain tube within the interior of the pouch for performing an exchange of used and fresh dialysis fluid in a sterile environment.
It is still yet another object of the present invention to provide a user wearable pouch having a sterile interior operable for receiving a catheter and a fill-drain tube from sources exterior to the pouch such that the user can connect the catheter and the fill-drain tube in a sterile environment.
It is still yet a further object of the present invention to provide a user wearable pouch having internally disposed hand covering elements for enabling the user to insert his hands into the hand covering elements and connect the user""s catheter to a fill-drain tube in the sterile interior of the pouch while manipulating the catheter and the fill-drain tube from a non-sterile environment external to the pouch.
Yet, it is still another object of the present invention to provide a peritoneal dialysis system having a user wearable pouch which provides a sterile environment for connecting the user""s catheter to a fill-drain tube connected to a fill bag and a drain bag for performing an exchange of used and fresh dialysis fluid.
Yet, it is a further object of the present invention for providing a method for performing an exchange of used and fresh dialysis fluid by connecting a user""s catheter to a fill-drain tube within the interior of a user wearable portable device.
In carrying out the above objects and other objects, the present invention provides a user wearable device for connecting a catheter of the user to a fill-drain tube for performing an exchange of dialysis fluid. The device includes a pouch having an interior formed by connected front and back sides. The front side of the pouch has an exposeable opening for inserting a fill-drain tube into the interior of the pouch. The back side of the pouch has an exposeable opening for inserting a catheter into the interior of the pouch.
The device may include at least one internally disposed hand covering element in communication with the exterior of the pouch for receiving at least one of the user""s hands in order to enable the user to connect the catheter to the fill-drain tube within the interior of the pouch for performing an exchange of dialysis fluid. The at least one internally disposed hand covering element may include a pair of mittens.
A fill-drain tube sleeve extending into the interior of the pouch for receiving the fill-drain tube when the fill-drain tube is inserted into the interior of the pouch may be connected to the exposeable opening of the front side of the pouch. A catheter sleeve extending into the interior of the pouch for receiving the catheter when the catheter is inserted into the interior of the pouch may be connected to the exposeable opening of the back side of the pouch. The exposeable openings may each include a peel away seal.
Attachment means may be connected to the pouch for attaching the pouch to the user. The attachment means may include a pair of strings connected to at least one of the front and back sides of the pouch for attaching the pouch around the user. The attachment means may include an adhesive attached to the back side of the pouch. The adhesive may be positioned around the exposeable opening of the back side of the pouch.
At least one of the pouch, the at least one internally disposed hand covering element, the fill-drain tube sleeve, and the catheter sleeve may be plastic and may be of a different color than any of the other elements. A catheter clamp may be connected to one of the front and back sides of the pouch within the interior of the pouch.
Further, in carrying out the above objects and other objects, the present invention provides a user wearable device for connecting an external end of a catheter connected to a user to a first end of a fill-drain tube connected at a second end to a fill bag and a drain bag for performing an exchange of dialysis fluid. The device includes a pouch having a closed interior, a first exposeable opening for inserting a first end of a fill-drain tube from an exterior of the pouch into the interior of the pouch, and a second exposeable opening for inserting an external end of a catheter of a user from the exterior of the pouch into the interior of the pouch. The device further includes a pair of hand covering elements in communication with the exterior of the pouch and internally disposed into the interior of the pouch for receiving the hands of the user in order to enable the user to connect the external end of the catheter to the first end of the fill-drain tube within the interior of the pouch for performing an exchange of dialysis fluid.
Also, in carrying out the above objects and other objects, the present invention provides a peritoneal dialysis system for a user having a catheter. The system includes a fill bag for feeding dialysis fluid, a drain bag for draining dialysis fluid, and a fill-drain tube connected at a first end by a Y connection to the fill bag and the drain bag. The system further includes a user wearable device having a closed pouch. The pouch has a first exposeable opening for inserting a second end of the fill-drain tube into the pouch and a second exposeable opening for inserting a catheter of a user wearing the pouch into the pouch in order to enable the catheter and the second end of the fill-drain tube to be connected together within the pouch by manipulation from outside of the pouch.
Still further, in carrying out the above objects and other objects, the present invention provides a method for performing an exchange of used and fresh dialysis fluid on a user having a catheter. The method includes providing a closed pouch having a first exposeable opening and a second exposeable opening. A catheter of the user is then inserted into pouch through the first exposeable opening. A fill-drain tube is then inserted into the pouch through the second exposeable opening. The catheter and the fill-drain tube are then connected together in the pouch by manipulation of the catheter and the fill-drain tube from outside of the pouch.
The method may further include attaching the pouch to the user after the catheter is inserted into the pouch through the first exposeable opening. The pouch may be attached to the user by using an adhesive positioned around the first exposeable opening on the outside of the pouch and then attaching the adhesive to the user around the catheter.
The method may also include connecting the catheter to the fill-drain tube by using a pair of hand covering elements in communication with the exterior of the pouch and internally disposed into the interior of the pouch for receiving the hands of the user.
The pouch may further include a catheter clamp in the pouch. The method may further include clamping the catheter with the catheter clamp prior to connecting the catheter to the fill-drain tube and removing the catheter clamp from the catheter after connecting the catheter to the fill-drain tube.
The advantages accruing to the present invention are numerous. For instance, the present invention provides a disposable and portable accessory that reduces the risk of peritonitis due to environmental contaminants carried in the air; increases the flexibility of scheduling exchanges outside of the traditional aspectic environment such as a spare bedroom thereby increasing the user""s mobility; provides a safe, pathogenic-free environment for dialysis fluid exchanges; and increases the desirability of peritoneal dialysis as a method of treating renal disease.
In essence, the present invention provides for the flexibility of doing a safe dialysis fluid exchange at any time in any environment setting. For example, users of the present invention do not need to worry about the surrounding environmental conditions for performing a safe dialysis fluid exchange (i.e., closed room with no other people in the room, ventilation system off, window closed, clean surface to lay supplies on, and antibacterial hand washing). This enables users to not want to skip treatment because of an event keeping the user away from a set location for performing a dialysis exchange or in the case where the surrounding environmental conditions are adverse. The present invention further reduces the need for setting aside a location such as a room dedicated to having the appropriate environmental conditions.